MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-11-25 for SEA-BOND DENTURE ADHESIVE UPPER WAFERS manufactured by Combe Inc..
[1452964]
Initial reporter stated that he believes that his wife, who has been recovering from a heart attack in a hosp in 2009, choked on sea bond denture adhesive wafers resulting in a stroke. The reporter said that he was not present when a hosp attendant misapplied the sea bond adhesive to his wife's dentures by using 2 or 3 uncut wafers to compensate for her ill-fitting dentures. He said that as the hosp staff attempted to clear the excess adhesive from her mouth/throat, she suffered a stroke and remains in the hosp.
Patient Sequence No: 1, Text Type: D, B5
[8334430]
Unable to get any further info from the initial reporter including unused product and medical records substantiating the stroke in spite of attempts to reach him by phone and mail. Results of evaluation of retained sample and batch records of lot r09b133 show no issues that suggest any defects associated with the lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450238-2009-00001 |
| MDR Report Key | 1546840 |
| Report Source | 00 |
| Date Received | 2009-11-25 |
| Date of Report | 2009-11-04 |
| Date of Event | 2009-09-28 |
| Date Mfgr Received | 2009-11-04 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2009-12-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1101 WESTCHESTER AVE. |
| Manufacturer City | WHITE PLAINS NY 10604 |
| Manufacturer Country | US |
| Manufacturer Postal | 10604 |
| Manufacturer Phone | 9144614481 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEA-BOND DENTURE ADHESIVE UPPER WAFERS |
| Product Code | KOM |
| Date Received | 2009-11-25 |
| Lot Number | R09B133 |
| ID Number | 1150900164 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMBE INC. |
| Manufacturer Address | WHITE PLAINS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-11-25 |